Label: SUN BUM PREMIUM MOISTURIZING SUNSCREEN ROLL ON SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 69039-642-01
- Packager: Sun Bum LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 4, 2022
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- Drug Facts
- Active ingredients
- Uses
- Warnings
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Directions
• shake well before use • apply liberally and spread by hand15 minutes before sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months of age: ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.-2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses
- Other information
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Inactive ingredients
water, hydrated silica, glycerin, polyglyceryl-6 stearate, styrene/acrylates copolymer, acrylates/c 12-22 alkyl methacrylate copolymer, polyster-8, tocopheryl acetate, lysolecithin, sclerotium gum, tetrasodium glutamate diacetate, pullulan, xanthan gum, polyglyceryl-6 behenate, citric acid, phenoxyethanol, ethylhexylglycerin, fragrance
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INGREDIENTS AND APPEARANCE
SUN BUM PREMIUM MOISTURIZING SUNSCREEN ROLL ON SPF 50
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69039-642 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z) BETASIZOFIRAN (UNII: 2X51AD1X3T) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) PULLULAN (UNII: 8ZQ0AYU1TT) XANTHAN GUM (UNII: TTV12P4NEE) POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69039-642-01 88 mL in 1 TUBE; Type 0: Not a Combination Product 01/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2022 Labeler - Sun Bum LLC (028642574)
